The present invention relates to hypodermic needle holders, suture needle disposal and disposal structures, and more specifically to a hypodermic needle holder and disposal structure that minimizes the risk of inadvertent needle sticks that may result from coupling or uncoupling a hypodermic needle from a hypodermic syringe or recapping a hypodermic needle, or may result from improper storage of a hypodermic needle while the needle is temporarily not in use.
Use and handling of hypodermic needles is a frequent occurrence in the field of medicine. Hypodermic needle systems typically consist of a hypodermic syringe that is quickly and easily removably attachable to a variety of hypodermic needle types and sizes by frictional engagement or by screw-on engagement, the latter of which is usually achieved using a LUERLOCK system. Handling and use of hypodermic needles inherently includes a certain amount of risk of accidental needle stick either to the person who may be administering an injection or to others in the immediate vicinity if a used hypodermic needle is improperly stored or carelessly placed prior to disposal.
Recapping a hypodermic needle after an injection is a likely cause of a large percentage of the composite risk factor for needle sticks in health care settings; most institutions discourage recapping of hypodermic needles under any circumstances. In some states and counties, safety laws prohibit recapping and other unsafe disposal practices. Unfortunately, this may also mean that the person responsible for disposing of a used hypodermic needle and syringe may have to travel more than a short distance to reach a sharps disposal container, thereby exposing more people than necessary to the potential hazard of incurring a needle stick and increasing their own risk for injury en route.
In some procedures, and for a given patient, there arises the need to re-use a needle during the procedure. For dentists who apply numbing medication in the oral cavity, repeated applications may be required with corresponding re-use of the needle. In other re-anesthetizing uses, such as during suturing, a needle may be re-used. For example, where the tissue requires further, later in time handling of the syringe and needle to either continue anesthization or to move on to another area on the patient""s body. In these and many other re-use scenarios, there is simply no proper procedure for interim protection of personnel, isolation of the used and to be used again needle. In some hospitals it is required that a drape cover the sterile field when significant time elapses between a procedure and the next procedure, or where when significant time elapses between a series of procedures. The use of a drape can pick up contamination and spread it with subsequent manipulation of the drape. The drape may catch on the needle or other objects in the sterile field and produce a stick through the drape or even catch the needle and cause it to drop to the floor when the drape is removed. Although the use of the drape to block dust and airborne contaminants, the increased risk of sticks, cuts and upset spills of the materials in the field increase several fold when the drape covers the objects in the field, and there is furter increase of accident each time the drape is handled after its initial deployment.
Even systems which are tauted to be xe2x80x9cneedle-lessxe2x80x9d continue to create a danger of needle stick. One recent system includes a seventeen gauge tube with a generally blunt (transverse even tubular end) end which is supposed to be protected by a sleeve. If anything, this system is just as apt to create accidental stick contamination as the needle end is hidden until it makes contact with the skin, and the temporary hiding of the needle in the sleeve causes unwarranted reliance on the sleeve with increased carelessness.
Further, in health care settings, certain intravenous medications are required to be given in incremented doses and are repeated until a desired effect is achieved. When this is the case, it is not uncommon to repeatedly fill the same hypodermic syringe with medication and to perform repeated intravenous injections into a port that leads directly to a vein or leads into an intravenous fluid line that terminates in a vein. This is usually the case, for example, with patients who have problems of an emergent nature, such as cardiac or respiratory arrest, or problems of an urgent nature such as heart failure or respiratory difficulty, or even for patients undergoing surgery. Because large volumes of fluid may be drawn up into a hypodermic syringe in anticipation of needing them, they are often drawn up using a large gauge hypodermic needle, such as an 18 or even a 16 gauge hypodermic needle for speed and convenience, and this may include the above xe2x80x9cneedle-lessxe2x80x9d system. Injecting an intravenous port with such a large gauge hypodermic needle even once could damage the membrane of the port, causing leakage at the port, and thus rendering the entire intravenous tubing useless such that it would have to be replaced. For this reason, administration of intravenous medications typically takes place using a smaller gauge hypodermic needle, usually less than a 20 gauge. This may require that the large gauge needle and the small gauge needle be intermittently exchanged for one another, and certainly requires that whichever needle is not in use be kept from contamination. In dire circumstances, where the patient""s condition may be serious and where the environment is likely to be somewhat chaotic as a result, the chances of improper placement of a used hypodermic needle increases significantly. Subsequently, the risk of hypodermic needle contamination increases, as does the risk for inadvertent needle stick for personnel who are caring for the patient, and even for family members or others who may be present.
In caring for a patient who receives frequent injections of any kind at the bedside, health care personnel may have their attention diverted from the task at hand by some distraction, and may subsequently place a used hypodermic needle on a bedside table or even on the bed beside the patient in order to address the distraction. Not only could this practice cause unintentional injury to the patient, but health care personnel and others who may have occasion to enter a patient""s room after the fact are also at risk of being stuck or otherwise injured by the stray hypodermic needle.
Yet another potentially harmful procedure is that of drawing up medications from a vial that requires puncture of a membrane in order to access the medication within the vial. Although the hypodermic needle is not biologically contaminated, this practice still presents the potential for injury to the health care worker or others, since it requires recapping the hypodermic needle until the medication is to be administered. Similarly, medications contained in scored glass vials that require breakage of the vial and drawing up of the medication through a hypodermic needle is another practice that increases risk of needle stick, primarily because of the need for recapping the hypodermic needle prior to giving the injection.
A carelessly placed hypodermic needle that causes injury may result in temporary incapacitation of the health care team member who sustains the injury. Prompt treatment of the injury is encouraged by most institutions, and incident reports are mandatory, thereby potentially compromising patient well-being by decreasing the number of staff available for immediate patient care.
Yet another potentially injurious situation is that involving hypodermic needle disposal. Disposing of an uncapped hypodermic needle, even into a designated sharps container, can be a dangerous act in itself. Because of the design of most sharps containers, if the container is nearly full, it can prove to be difficult if not impossible to safely insert an exposed hypodermic needle into the box without injury either from the hypodermic needle being inserted or from other needles that may have become lodged in the opening of the box.
While hypodermic needles and syringes are likely the cause of most needle stick injuries, surgical needles and other small sharps containers commonly used in a health care setting are also potential hazards if not disposed of properly. Because suture needles are quite small, simple suturing at a patient""s bedside may result in misplacement of the small suture needle and attached thread should it not be immediately disposed of or placed in a safe location prior to its disposal. A stray needle in the patient""s bed or on the floor could result in patient injury or injury to health care workers, patient family, or others who may come in contact with the patient or who may have occasion to be in the patient""s room. Lack of an appropriate disposal container in an operating room could also lead to misplacement of suture needles during a patient""s surgery; this could be particularly problematic, and could place the patient in unnecessary danger by delaying the completion of the surgery until all suture needles are located.
Other persons at risk for injury from needle stick include family members or unskilled lay persons who may help to care for patients in a home setting and who may regularly assist, for example, with subcutaneous administration of medications such as insulin. Other persons at risk include paramedics and emergency health workers who are always on the move, continually working in harried, difficult conditions and have no prepared surgical field to use as a base of operations. With paramedics, for example, time is of the essence. If too much time is required in either disposing of or temporarily storing a needle, the parametic may toss it on the ground where it may contaminate others or toss it in the medical kit. Without a proper, inviting and very available place to both store needles during extended procedures and to at least safely and temporarily dispose of needles on the move, needle sticks and the like will remain a major problem to emergency health professionals.
Yet another situation where accidental needle sticks or other injury can occur is after an intravenous line is initiated on a patient. Because the intravenous catheters used are catheter-over-the needle systems, once the catheter is in place, the needle is extracted and disposed of. Whether the intravenous line is started in an emergency situation that may be chaotic, or whether started in the most optimal of situations, the needle may be improperly placed on whatever surface is nearest at hand so that the catheter may be secured and fluids or medication may be administered. Should the needle be forgotten once the procedure is complete, it will pose a risk for those in the immediate vicinity. Some new catheter systems include safety devices, but use of such devices still involves the needle being left out with continued danger of needle sticks at the point.
Although most, if not all, health care institutions have designated procedures for the proper use and disposal of needles, and although most institutions additionally require health care workers to attend continuing education classes for learning safe handling and disposal of sharps and other biologically contaminated equipment, accidental needle sticks continue to occur and are an ongoing problem. The risk of accidental needle stick is cause for serious concern, both to health care workers and to others who may be exposed to the use of hypodermic syringes and needles of any kind, due to the existence and transmissibility of life threatening blood-borne diseases such as hepatitis, and Acquired Immune Deficiency Syndrome (AIDS).
What is therefore needed is a device and method that is easy and convenient to use and that will minimize the risk associated with handling and disposal of hypodermic needles and hypodermic syringes. The proposed device should be useable by trained health care personnel, as well as by unskilled lay persons such as patients, family members, and other care givers. The proposed device should be able to accommodate a variety of sharps or similarly small biologically contaminated items that would be ill disposed of in an ordinary trash can.
Numerous attempts have been made in the prior art to design a safe disposal container for hypodermic syringes and needles. However, such devices do not allow for both the removal and attachment of hypodermic syringes and needles in a safe manner. Such devices also do not teach their sterilization to enable them to be used in any capacity other than their capacity for disposal. All of the prior devices for holding and facilitating safe disposal of the needles will destroy the sterility of the sterile field. Any health care worker walking about with an open container full of contaminated needles should not be allowed anywhere near a sterile field. Many of the devices are not only too contaminated, they are too large for the sterile field. Most of the prior devices which will accommodate large numbers of syringe needles, by being contaminated, require the health care workers to carry the needles to it, again exacerbating the handling problem and increasing danger to others from open carriage of the contaminated material. In prior devices, no attempt is made to either start with a sterile space nor to isolate stored needles from other needles which have been contaminated by other patients.
For example, U.S. Pat. No. 5,046,612 issued to Mostarda et al. and U.S. Pat. No. 4,917,243 issued to Abrams both provide hand held receptacles that extract hypodermic needles from hypodermic syringes. As such the used hypodermic needles are longitudinally placed inside the receptacle and removed from the hypodermic syringe to thereby reduce the risk of injury from the hypodermic needle tip. Both inventions provide different means for inserting the hypodermic needle into the receptacle longitudinally such that the risk of exposure to the sharpened hypodermic needle tip is reduced. However, there are no methods for reusing the hypodermic needle as is necessary when re-filling a hypodermic syringe with fluid or medication or re anesthetizing a patient, or re-injection of a joint.
In U.S. Pat. No. 5,057,656 issued to Galber, a disposal container for hypodermic needles is provided. The container includes a top with suitability shaped openings for the removal of hypodermic needles from hypodermic syringes. Used hypodermic needles are disposed inside the container to protect the health care worker. Also, the needles inserted into the foam filled container can""t be reversed and used again as foam fills the needle opening.
Furthermore, in U.S. Pat. No. 4,375,849 issued to Nahifl and U.S. Pat. No. 4,351,434 issued to Elisha, hypodermic needles are disposed in a cylindrical container through an opening in the container top. However, such containers pose a risk of injury to the health care worker because the container is usually held with a hand that can be punctured by the exposed hypodermic needle tip as it is inserted into the container. As such, these containers do not provide a safe method of disposal. Similarly, U.S. Pat. No. 4,995,871 issued to Sasaki et al. And U.S. Pat. No. 4,984,686 issued to Shillington provide enclosure lids that extract the hypodermic needle from the hypodermic syringe and then dispose of the hypodermic needle in an attached container. However, both devices are complex and not easily manufactured and do not provide for the safe storage of exposed hypodermic needle tips.
Additionally, U.S. Pat. No. 4,892,191 issued to Nakamura, discloses a container for the removal and disposal of press or slip type hypodermic needles attached to a hypodermic syringe while U.S. Pat. No. 4,802,579 issued to Hall et al. discloses a container which removes and disposes of hypodermic needles that use screw threads to attach the hypodermic syringe. In both devices, the hypodermic needle is inserted into the disposal container through an opening and engaged thereby. The opening is then used to remove the hypodermic needle from the hypodermic syringe and the exposed hypodermic needle is dropped down into the container. However, neither of these devices provide means for storing the exposed hypodermic needles while being attached or removed from the hypodermic syringe before being disposed.
Furthermore, U.S. Pat. No. 4,191,264 issued to Shinall discloses a removal and disposal device for hypodermic needles. The device comprises individual containers that remove and store the used hypodermic needle in a tacky substance. As such, the device is complicated and expensive to manufacture and does not allow needle re-use. Similarly, U.S. Pat. No. 4,452,358 discloses a box-like device wherein the hypodermic needle is destroyed while being removed from the hypodermic syringe and the container includes multiple compartments and openings for the disposal of other medical instruments such as scalpel blades.
As can be seen from the related prior art, numerous devices have been designed for the disposal of hypodermic syringes and needles. However, none of the prior art devices provide an apparatus that can safely remove, attach and store the hypodermic needle and then properly dispose of the hypodermic needle after use.
What is therefore needed is an inexpensive device that protects the health care worker from inadvertent needle sticks while handling hypodermic needles and syringes. The needed device and method should be simple to use and therefore optimal for use by both trained professional health care workers as well as unskilled lay persons who may have need of using hypodermic syringes and needles in a home care setting. Additionally, there exists a need for provision of both storage of hypodermic needles, with or without a hypodermic syringe attached, and for disposal of hypodermic needles quickly and safely after their use and subsequent detachment from hypodermic syringes. Furthermore, there is a need for containment and disposal of other sharp objects such as suture needles, or other small items that may be biologically contaminated and that would be more appropriately disposed of in a biological waste container rather than in a trash can.
The needle holder of the present invention has a variety of features that make it an optimal device for safe storage and disposal of hypodermic needles. Further, the needle holder of the present invention is also able to accommodate surgical needles or other small sharps or biologically contaminated articles, and may be easily and conveniently employed in a variety of settings. Alternative embodiments of the present invention will accommodate double-ended hypodermic needles, and larger versions of hypodermic needles such as thoracic, cardiac, or spinal needles.
In the preferred embodiment of the present invention, there is provided a hypodermic needle holder which works with a hypodermic needle having a needle hub adjacent a needle shaft and terminating at a needle tip. The hypodermic needle holder comprises a body portion and a lid portion, the body portion of which defines a compartment having a plurality of needle retainers disposed in a side-by-side relation therein. The needle retainers are sized and configured to frictionally engage the needle hub of a hypodermic needle in a manner wherein the hypodermic needle is fixedly contained within the needle retainer. The needle retainers are frustoconical or conically or of tapering shape and also specially internally shaped for frictional retention of the hypodermic needles. The compartment has a generally rectangular configuration and is optimally formed from a rigid and durable plastic material. The lid portion of the hypodermic needle holder is moveable between an open position where the needle retainers are accessible and a closed position whereat the needle retainers are shielded within the hypodermic needle holder.
The hypodermic needle holder of the present invention also includes a receptacle into which smaller sized needles such as surgical needles may be placed after use. Furthermore, this receptacle may be used for small items such as cotton balls, gauze pads, or discontinued intravenous catheters that may be biologically contaminated and that would be best disposed of in a bio-hazardous waste container. The material from which the needle holder may be constructed may be clear in order to facilitate a visual count of suture needles as well as a count of engaged and stored hypodermic needles.
In an alternative embodiment of the present invention, the size of the overall hypodermic needle holder and of the needle retainers themselves are elongated in order to contain longer hypodermic needles such as cardiac, thoracic, or spinal needles.
In yet another alternative embodiment of the present invention, a container is provided with a slightly larger opening in order to accommodate a double ended hypodermic needle such as those used in many dental practices, as well as those used in the medical profession primarily by phlebotomists and in conjunction with devices such as VACUTAINERS.
Further there is provided a method for transferring attachment of a hypodermic needle to or from a hypodermic syringe through the use of a hypodermic needle holder which includes an opening with at least one engaging needle retainer disposed therein. The method includes frictionally engaging the hypodermic needle to the needle retainer both by insertion friction and turning friction. The hypodermic syringe is advanced into the opening of a hypodermic needle holder and subsequently into a needle retainer space and retainer structure for initial axial frictional engagement to cause the hypodermic needle to be frictionally engaged with the retainer structure. The hypodermic syringe can be disengaged from the hypodermic needle by a turning motion against the friction and locking holding power of the needle retainer, to disengage the needle from its LUER fitting. The hypodermic syringe can be re-engaged onto the hypodermic needle by approach of the syringe, and physical engagement of the LUER fitting by a turning motion against the friction and locking holding power of the needle retainer, to re-engage the LUER fitting. Once re-engaged, a simple axial pulling of the syringe and LUER attached needle will disengage the hypodermic needle from the needle retainer. If needed, the hypodermic needle and syringe combination can be disengaged from the needle retainer and removed from the opening of the hypodermic needle holder for further use. By providing a relatively larger structure than a simple cap, movement of the hypodermic needle into and from its storage area is accomplished while the fingers and hand not holding the hypodermic syringe can support the hypodermic needle holder significantly far from the area of entrance of the needle into the hypodermic needle holder. Furthermore, the hypodermic needle holder includes an openable and closable lid portion for selectively accessing the needle retainer wherein the lid portion must be opened prior to advancing the hypodermic syringe into the opening of the hypodermic needle holder.
The present invention further includes a method of removing a hypodermic needle from a hypodermic syringe that includes a hypodermic needle holder having an opening with at least one needle retainer disposed therein. The method comprises advancing a hypodermic syringe with a hypodermic needle coupled thereto into the hypodermic needle holder and subsequently into the needle retainer. Next, the hypodermic needle is frictionally engaged to the needle retainer. The hypodermic syringe is then uncoupled from the hypodermic needle, leaving the hypodermic needle engaged within the needle retainer. The hypodermic syringe and needle may be coupled via a frictional engagement wherein uncoupling the hypodermic syringe from the hypodermic needle comprises pulling the hypodermic syringe away from the hypodermic needle. Alternatively, the hypodermic syringe and needle may be coupled via a LUER fitting such that uncoupling the hypodermic syringe from the hypodermic needle comprises rotation of the hypodermic syringe to disengage the hypodermic needle. Furthermore, the hypodermic needle holder includes a lid portion such that the lid portion must be opened prior to the advancement of the hypodermic syringe into the hypodermic needle holder.